NL-OMON20824
Recruiting
Not Applicable
Clinical Validation of a Point of Care (POC) Test for the Measurement of Infliximab (IFX) or Adalimumab (ADL) Levels in the Serum of Inflammatory Bowel Disease (IBD) Patients
ProciseDx0 sites320 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ProciseDx
- Enrollment
- 320
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult (\=16 years old) Males and females with either CD or UC.
- •2\.Patients must have a confirmed diagnosis of CD or UC based on results of a complete medical evaluation and assessment by a physician specialized in inflammatory bowel disease.
- •3\.Patients must be undergoing maintenance phase IFX or ADL therapy at the time of the first blood collection used for the current study
- •4\.Patients must have at least 24 months of follow up after the baseline sample.
- •5\.Written informed consent must be provided.
Exclusion Criteria
- •1\.Patients not undergoing maintenance phase IFX, ADL or biosimilar therapy at time of baseline sample collection.
- •2\.Patients not diagnosed with either CD or UC.
- •3\.Receipt of any blood products within 3 months prior to the baseline sample collection
- •4\.Participation in a clinical trial at the baseline sample collection or within the 8 weeks prior to the baseline sample collection.
Outcomes
Primary Outcomes
Not specified
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